Category: Covid-19 Vaccine

While everyone celebrated this months news that not one but two experimental vaccines against Covid-19 have proved at least 90% effective at preventing disease in late-stage clinical trials, research into understanding how the Sars-CoV-2 virus, which causes Covid-19, interacts with the human immune system never paused.

There are plenty of questions still to answer about the Pfizer/BioNTech and Moderna vaccines: how well will they protect the elderly, for example, and how long for? Which aspects of the immune response that they elicit are protective and which arent? Can even better results be achieved, with vaccines that target different parts of the immune system?

We are likely to need several Covid-19 vaccines to cover everyone and as a contingency, in case the virus mutates and escapes the ability of one vaccine to neutralise it, a real possibility in light of the discovery of an altered form of Sars-CoV-2 infecting European mink. But we also need better methods of diagnosing and treating the disease. The recent suspension of two major vaccine trials due to serious adverse events is a salutary reminder that theres much still to learn and a pandemic, while no one would wish for one, provides scientists with a golden opportunity for learning.

Like most Covid-19 vaccine candidates, the Pfizer and Moderna vaccines are injected into the muscle, from where they enter the bloodstream and stimulate the production of antibodies to Sars-CoV-2 (specifically to the protein that forms the spikes covering its surface). But antibodies are only one component of the bodys adaptive immune response, which develops over time, in response to invasion by a virus or other pathogen. There is also innate immunity, which we are born with and that is mobilised instantly upon infection, but is not tailored to any specific pathogen. There are a lot of moving parts to this, says immunopharmacologist Stephen Holgate, of the University of Southampton in the UK, who wonders why scientists have focused on so few of them.

The UK governments joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

1 All those 80 years of age and over and health and social care workers.

2 All those 75 and over.

3 All those 70 and over.

4 All those 65 and over.

5 Adults under 65 at high at risk of serious disease and mortality from Covid-19.

6 Adults under 65 at moderate risk of at risk of serious disease and mortality from Covid-19.

7 All those 60 and over.

8 All those 55 and over.

9 All those 50 and over.

10 Rest of the population.

Holgate is one of the founders of Synairgen, a University of Southampton spin-off company that has been testing inhaled interferon-beta, an important innate defence that works by shutting down viral replication, as a treatment for Covid-19. A major international study backed by the World Health Organization, called Solidarity, showed that interferon-beta was not effective in treating hospitalised patients, but more recently Synairgen has published the results of a small pilot study suggesting that given in patients with milder disease and inhaled rather than injected under the skin it enhanced recovery.

The reason bats are able to harbour these viruses in such large numbers is that they have such a strong interferon response, Holgate says. That is why they dont develop disease. Synairgen is now testing whether interferon-beta can prevent hospitalisation in patients who inhale it soon after testing positive, at home. If the approach works, he says, the advantage is that it will continue to do so even if the virus mutates, since interferons action does not depend on the structure of the virus.

Another immune response that has received a lot of attention in the context of Covid-19 is that of T-cells. Along with B-cells, which generate antibodies, T-cells form part of the adaptive immune system and they perform two main functions: they help B-cells do their job and they kill infected cells. Both B- and T-cells retain a memory of past infections, meaning they are mobilised more quickly when a pathogen appears for a second or subsequent time.

In May, US researchers reported that T-cells extracted from human blood samples taken before 2019, and exposed to Sars-CoV-2, showed a memory for coronavirus infection. This suggested that previous exposure to different coronaviruses, such as those that cause the common cold, might be sufficient to prime T-cells and raised hopes that they could protect against Covid-19. Those hopes were bolstered by a report of people fighting off infection even though they developed only a T-cell response and no antibodies, though the number of patients in that study was small and the evidence therefore hard to interpret. Lockdown sceptics pointed to these studies as evidence that more of the population was protected against Covid-19 than was thought, but some immunologists say they did so prematurely.

As Akiko Iwasaki of Yale University in the US explains: T-cells cannot prevent infection, they can only respond when there is an infection. So although they could potentially reduce the severity of the disease, they cant stop its transmission between people. Also, there is still no proof that the T-cell response is helpful. Its likely that both antibodies and T-cells are important in protection, but we have zero evidence so far for protection of any kind, says immunologist Zania Stamataki of the University of Birmingham in the UK.

Obtaining that evidence will involve seeing how people either exposed to the virus naturally or vaccinated against it respond upon reinfection. Vaccine trials could provide such evidence, as could a number of studies of the correlates of protection in natural infection. Iwasakis group, for example, is comparing the immune responses of unexposed, sick and recovered individuals, while virologist Florian Krammer of the Icahn School of Medicine at Mount Sinai, New York City, and colleagues are tracking those responses longitudinally, in thousands of people exposed naturally over time. Then there are the so-called challenge trials that are due to be launched by Chris Chiu of Imperial College London and colleagues in January.

In the first stage of these trials, about 30 young, healthy individuals will have their immune status measured before and after deliberate exposure to Sars-CoV-2. The trials will generate data on immune responses in the blood, but also, because the virus will be delivered via the nose, on any local immune response that develops there. Both antibodies and T-cells are made at the bodys mucosal membranes, including those lining the airways, as well as in the blood, and this mucosal immunity is causing excitement among some scientists, though vaccine makers have so far paid it scant attention.

The virus comes in and it lands on your mucosal surfaces, explains Krammer. If its neutralised right there, its game over. Unable to replicate and penetrate deeper into the bodys tissues, the virus is prevented from causing not only disease but also infection, meaning the person can transmit it no further. Its not yet clear if the Pfizer and Moderna vaccines block transmission, as well as preventing disease, but a vaccine that did so could bring the pandemic to an end sooner. And it could do it without the need for an injection just by using a nasal spray or inhaler.

Antibodies come in different forms that vary according to their biological properties and the tissues in which they are expressed. Like the Pfizer and Moderna vaccines, most Covid-19 vaccines in development elicit IgG antibodies in the blood, but the main antibody secreted in the upper respiratory tract, essentially the nose and throat, is IgA.

In June, in a study that has now been accepted for publication in a peer-reviewed journal, a French group detected IgA antibodies in the blood of Covid-19 patients as early as a day after the onset of their symptoms. IgA levels peaked three weeks later, a week before IgG peaked. Then in August, a Canadian group reported the same finding in saliva. The IgA response comes up early and dissipates quickly, whereas the IgG response persists, says immunologist Jennifer Gommerman of the University of Toronto, one of the lead authors on that study.

The short duration of that IgA response might not matter as much as the fact that it peaks early within a day or two of the innate response. The adaptive immune system kicks in if that innate response fails its the second line of defence but if you could enhance that early IgA response you could still block infection and prevent the person from feeling ill at all. Researchers have some reason to hope this may be possible.

IgA occurs in different forms at the mucosal membranes and in the blood. In the blood, it circulates singly, while at the membranes lining the airways it is secreted in pairs or even clusters. There is some evidence that doubled up, IgA antibodies capacity to neutralise the virus increases significantly, probably because each pair has twice as many binding sites at which to capture the invader. If you have an antibody on its own, it works pretty well, says Guy Gorochov of the Sorbonne University in Paris, who led the French study of IgA. If you have a pair of them, it is far more effective.

An inhaled vaccine against flu that elicits a local immune response in the airways already exists and there are Covid-19 vaccines in development that do the same, though they are a long way from clinical trials. Researchers are intrigued by the possibility that, besides antibodies, such a vaccine could also stimulate a kind of T-cell that is produced in the lining of the respiratory tract, called tissue-resident memory T-cells, and that these could contribute to shutting down infection rapidly. Whats more, measuring this local response could give an early and accurate indication of a persons capacity to fight off the disease. The work weve done in the past, with other respiratory viruses, suggests that IgA in the nose is often a much better correlate of protection than circulating antibodies, says Chiu.

Theres a lot more work to be done before the human immune response is fully leveraged to fight Covid-19 and what is learned in the context of this disease could be applied to others, especially when it comes to therapies that modify the human immune response rather than the virus. For now, though, most experimental vaccines and therapies target antibodies, which are virus-specific and one type of antibody, IgG, in particular. One piece of good news, where these are concerned, is that several studies, including Gommermans and Krammers, have now demonstrated that IgG levels remain high for up to eight months after infection. The same durability of antibody response has yet to be demonstrated for any vaccine, but these findings bode well.

The best news of all is that at least two vaccines now exist that seem to protect us against Covid-19 and that the chances are high that some of the most vulnerable people in the world will benefit from them within months. It remains an extraordinary and unprecedented feat to have built such a vaccine, and shown it to be safe and effective, before the disease they protect against is one year old and before the pandemic is over.

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Why the race to find Covid-19 vaccines is far from over - The Guardian

LONDON (AP) Drugmaker AstraZeneca said Monday that late-stage trials showed its COVID-19 vaccine is highly effective, buoying the prospects of a relatively cheap, easy-to-store product that may become the vaccine of choice for the developing world.

The results are based on an interim analysis of trials in the U.K. and Brazil of a vaccine developed by Oxford University and manufactured by AstraZeneca. No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine.

AstraZeneca is the third major drug company to report late-stage data for a potential COVID-19 vaccine as the world waits for scientific breakthroughs that will end a pandemic that has pummeled the world economy and led to 1.4 million deaths. But unlike the others, the Oxford-AstraZeneca vaccine doesnt have to be stored at freezer temperatures, making it potentially easier to distribute, especially in developing countries.

I think these are really exciting results, Dr. Andrew Pollard, chief investigator for the trial, said at a news conference. Because the vaccine can be stored at fridge temperatures, it can be distributed around the world using the normal immunization distribution system. And so our goal to make sure that we have a vaccine that was accessible everywhere, I think weve actually managed to do that.

The Oxford-AstraZeneca vaccine was 90% effective in preventing COVID-19 in one of the dosing regimens tested; it was less effective in another. Earlier this month, rival drugmakers Pfizer and Moderna reported preliminary results from late-stage trials showing their vaccines were almost 95% effective.

While the AstraZeneca vaccine can be stored at 2 degrees to 8 degrees Celsius (36 degrees to 46 degrees Fahrenheit), the Pfizer and Moderna products must be stored at freezer temperatures. In Pfizers case, it must be kept at the ultra-cold temperature of around minus-70 degrees Celsius (minus-94 Fahrenheit).

The AstraZeneca vaccine is also cheaper.

AstraZeneca, which has pledged it wont make a profit on the vaccine during the pandemic, has reached agreements with governments and international health organizations that put its cost at about $2.50 a dose. Pfizers vaccine costs about $20, while Modernas is $15 to $25, based on agreements the companies have struck to supply their vaccines to the U.S. government.

All three vaccines must be approved by regulators before they can be widely distributed.

Oxford researchers and AstraZeneca stressed they werent competing with other projects and said multiple vaccines would be needed to reach enough of the worlds population to end the pandemic.

We need to be able to make a lot of vaccine for the world quickly, and its best if we can do it with different technologies so that if one technology runs into a roadblock, then weve got alternatives, weve got diversity, professor Sarah Gilbert, a leader of the Oxford team, told The Associated Press. Diversity is going to be good here, but also in terms of manufacturing, we dont want to run out of raw materials.

AstraZeneca said it will immediately apply for early approval of the vaccine where possible, and it will seek an emergency use listing from the World Health Organization, so it can make the vaccine available in low-income countries.

The AstraZeneca trial looked at two different dosing regimens. A half-dose of the vaccine followed by a full dose at least one month later was 90% effective. Another approach, giving patients two full doses one month apart, was 62% effective.

That means that, overall, when both ways of dosing are considered, the vaccine showed an efficacy rate of 70%.

Gilbert said researchers arent sure why giving a half-dose followed by a larger dose was more effective, and they plan to investigate further. But the answer is probably related to providing exactly the right amount of vaccine to get the best response, she said.

Its the Goldilocks amount that you want, I think, not too little and not too much. Too much could give you a poor quality response as well ..., she said. Im glad that we looked at more than one dose because it turns out to be really important.

The vaccine uses a weakened version of a common cold virus that is combined with genetic material for the characteristic spike protein of the virus that causes COVID-19. After vaccination, the spike protein primes the immune system to attack the virus if it later infects the body.

Peter Openshaw, professor of experimental medicine at Imperial College London, said the finding that a smaller initial dose is more effective than a larger one is good news because it may reduce costs and mean more people can be vaccinated with a given supply of the vaccine.

The report that an initial half-dose is better than a full dose seems counterintuitive for those of us thinking of vaccines as normal drugs: With drugs, we expect that higher doses have bigger effects, and more side-effects, he said. But the immune system does not work like that.

The results reported Monday come from trials in the U.K. and Brazil that involved 23,000 people. Of those, 11,636 people received the vaccine while the rest got a placebo.

Overall, there were 131 cases of COVID-19. Details on how many people in the various groups became ill werent released Monday, but researchers said they will be published in the next 24 hours.

Late-stage trials of the vaccine are also underway in the U.S., Japan, Russia, South Africa, Kenya and Latin America, with further trials planned for other European and Asian countries.

Researchers said they expect to add the half dose-full dose regimen to the U.S. trial in a matter of weeks. Before doing so they must discuss the changes with the U.S. Food and Drug Administration.

The AstraZeneca trials were paused earlier this year after a participant in the U.K. study reported a rare neurological illness. While the trials were quickly restarted in most countries after investigators determined the condition wasnt related to the vaccine, the FDA delayed the U.S. study for more than a month before it was allowed to resume.

AstraZeneca has been ramping up manufacturing capacity, so it can supply hundreds of millions of doses of the vaccine starting in January, Chief Executive Pascal Soriot said earlier this month.

Soriot said Monday that the Oxford vaccines simpler supply chain and AstraZenecas commitment to provide it on a nonprofit basis during the pandemic mean it will be affordable and available to people around the world.

This vaccines efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency, Soriot said.

British Health Secretary Matt Hancock said he felt a great sense of relief at the news from AstraZeneca.

Britain has ordered 100 million doses of the vaccine, and the government says several million doses can be produced before the end of the year if it is approved by regulators.

Just months ago, the idea that by November we would have three vaccines, all of which have got high effectiveness I would have given my eye teeth for, Hancock said.

From the beginning of their collaboration with AstraZeneca, Oxford scientists have demanded that the vaccine be made available equitably to everyone in the world so rich countries cant corner the market as has happened during previous pandemics.

Leaders of the worlds most powerful nations on Sunday agreed to work together to ensure affordable and equitable access to COVID-19 drugs, tests and vaccines.

If we dont have the vaccine available in many, many countries, and we just protect a small number of them, then we cant go back to normal because the virus is going to keep coming back and causing problems again, Gilbert said. No one is safe until were all safe.

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This story has been updated to correct that the Moderna vaccine needs to be stored at freezer temperatures, but not the ultra-cold temperatures required for the Pfizer one.

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Associated Press writer Jill Lawless contributed to this story.

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Follow APs coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak

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3rd major COVID-19 vaccine shown to be effective and cheaper - The Associated Press

AstraZenecas COVID-19 vaccine is up to 90% effective, the company said Monday in a press release, making it the third pharmaceutical firm to report promising vaccine news, following Pfizer and Moderna. AstraZeneca, which partnered with University of Oxford researchers to develop its two-dose vaccine, reported efficacy from two different dosing regimens; one led to 62% efficacy and another to 90%, with an average, the company says, of 70%.

The companys vaccine was initially developed by Oxford scientists, who started with a disabled cold virus that commonly infects chimpanzees. Its a more traditional approach than the strategy used by Moderna and Pfizer, both of which relied on the genetic mRNA code from SARS-CoV-2, the virus that causes COVID-19. The Oxford team used the cold virus as a molecular Trojan horse (technically known as a vector) to disguise the true payload: material from SARS-CoV-2, which triggers the human immune system into action. The chimp virus helps to deliver the coronavirus more efficiently without causing actual COVID-19.

Among people who received a half dose of the AstraZeneca vaccine, and then a full dose about a month later, about 90% were protected from symptomatic COVID-19 illness. Among those getting two full doses of vaccine a month apart, 62% were protected from getting sick. None of the people receiving either regimen were hospitalized or became severely ill.

The data, part of a scheduled efficacy review, are based on 131 cases of COVID-19 among both the vaccinated and placebo groups. But because the full set of data has not been published, vaccine expertsincluding regulatorsare still trying to figure out why the different regimens led to different results. The different levels of efficacy with two different dosing regimens is scientifically intriguing, says Dr. Jessica Justman, associate professor of medicine in epidemiology at Columbia Mailman School of Public Health and senior technical director of ICAP at Columbia, a global public health services group.

One possible explanation relates to the vaccines design. Because it relies on a weakened cold virus to deliver the COVID-19 viral material, recipients immune systems may actually be mounting a response to the cold virus rather than the coronavirus. Halving the first dose helps to dampen this immune response to the cold virus, possibly increasing the response to the coronavirus.

We know with other [cold] virus vectors you do get immunity to the vector, says Dr. Anna Durbin, professor of international health at Johns Hopkins University and an investigator running one of the U.S. COVID-19 vaccine trials. It may be that the higher [first] dose induced more immunity against the vector so when the second dose came in, it didnt express the [SARS-CoV-2] protein as well. But we dont know that yet.

Its also possible that the discordant results have something to do with the way the trials were conducted. Testing of the half dose+full dose regimen, which was done in the U.K., began after the companys combined U.K.-Brazil trials had started and many participants already received the originally planned two full doses. Fewer people received the former combinationnearly 9,000 people received two full doses, while only 2,700 received the half dose+full dose regimen. Those in the latter group have been followed for a shorter period of time, and simply may not have had enough time to develop COVID-19.

In the U.S. trials, however, all participants are still receiving two full doses of vaccine. Results from those tests could help to explain some of the discrepancy. I will be very interested to see if we are going to see the same results or different results from the [U.S.] trial, Durbin says. She also notes that it would be challenging to change the U.S. trials at this point to include a half-dose+full dose regimenthe vaccine trial design was vetted and approved before they began, and modifying them would potentially compromise the data, as scientists would no longer be comparing similar groups of people across different sites.

The U.K. and Brazil data also suggest that the AstraZeneca vaccine may be helping to prevent transmission of the virus. If true, that would be an added bonus, says Durbin. However, the company did not say how many of the 131 confirmed COVID-19 cases among trial participants tested positive but experienced no symptoms. In the U.K. and Brazil studies, the researchers tested volunteers weekly, so they could understand how many people developed asymptomatic disease, and study them for their response to the vaccine. In the U.S. study, people are only tested if they develop COVID-19 symptoms, meaning that among those who are positive, researchers are comparing how sick the vaccinated people get to how ill those receiving placebo get.

All of which means that the AstraZeneca results, while encouraging, leave a lot of unanswered questions. Its not clear how the U.S. Food and Drug Administration (FDA) will interpret the data, and whether it will recommend the half dose+full dose regimen, or require more data to be collected about that approach.

One factor that may play a role: with infections continuing to rise around the world, its becoming critical to vaccinate as many people as possible, as quickly as possible. And if the half dose+full dose regimen proves more effective when the final data are revealed, then it also has the advantage of immunizing more people with the same amount of vaccine. Its a win-win, says Justman. You get better protection and provide it to more people.

But its still too early to tell whether thats the case, and also too early to start making decisions about which vaccine you might choose if given the option. The advice I would give today, on Nov. 23, is to sit back and wait and see what additional information comes out, says Justman. As much as we want all the information right now, I think we need to just be patient and let things play out through proper scientific and regulatory channels.

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Why Does the AstraZeneca COVID-19 Vaccine's Efficacy Vary So Much? Here's What We Know - TIME

The CDC's Advisory Committee on Immunization Practices met to discuss whether to recommend use of any Covid-19 vaccine that the US Food and Drug Administration might authorize.

Volunteers in vaccine trials have reported they frequently feel flu-like effects after getting vaccinated, and members of the ACIP -- as well as liaison representatives who take part in the discussion -- said that could affect people's willingness to get vaccinated in the first place, or to get the second dose of the two-vaccine regimen.

"As a practicing physician, I have got to be sure my patients will come back for the second dose. We really have got to make patients aware that this is not going to be a walk in the park," Dr. Sandra Fryhofer of the Emory University School of Medicine, representing the American Medical Association, told the meeting.

"They are going to know they got a vaccine. They are not going to feel wonderful."

The whole point of vaccination is to cause an immune response in the body and that can sometimes cause flu-like symptoms such as body aches, or even fever and a headache.

Patricia Stinchfield of Children's Hospitals and Clinics of Minnesota, representing the National Association of Pediatric Nurse Practitioners, said providers must be ready to explain this to people getting any vaccine.

"These are immune responses, so if you feel something after vaccination, you should expect to feel that. And when you do, it's normal that you have some arm soreness or some fatigue or some body aches or even some fever," Stinchfield told the meeting. Some people may feel bad enough to need to stay home from work for a day, she said.

Dr. Paul Hunter of the city of Milwaukee health department and a voting member of the committee, said it will be important for the first people to get vaccinated to describe these experiences to others.

Boosting confidence in a vaccine

"The people who highly value getting the vaccine soon and fast, early, are going to be really helpful to everyone else. And I think we really are going to need to honor them, because they are going to let us know how it feels," he said. "And I think these people are likely to be health care workers who are likely to be up for that kind of task."

Public willingness to get a coronavirus vaccine has been steadily dropping since the spring, but it might improve when people start to hear more about the safety and efficacy of the various vaccines in the works, the CDC's Dr. Sara Oliver told the committee during the five-hour-long meeting.

Oliver said the CDC has been looking at various surveys on attitudes and noted that anywhere between 40% and 80% of those surveyed said they'd be willing to get vaccinated.

"Many adults reported intentions to receive Covid vaccine. But concerns were raised around side-effects, unknown efficacy and the speed of the (authorization) process," Oliver told the meeting.

Vaccine acceptance was highest among Asian-Americans and lowest among African-Americans, Oliver said. That's of concern because ACIP wants to make sure any vaccine that is approved gets to the groups most affected by the pandemic, and Blacks are among the hardest hit by Covid-19.

Nurses were also a concern. One survey showed that while nurses agreed vaccines were likely to be safe and effective, only 34% would voluntarily get vaccinated, Oliver said.

Members of ACIP said they thought these fears could be addressed with education campaigns and as people learned about data showing that, for example, the Pfizer and Moderna vaccines were about 95% effective in preventing symptomatic disease with no significant safety concerns.

Allocating the vaccine

Fair access is at the top of the list, ACIP committee members said in a document published at the start of the meeting.

"How do characteristics of the vaccine and logistical considerations affect fair access for all persons?" they asked in the document, released in the CDC's MMWR report.

"Does allocation planning include input from groups who are disproportionately affected by Covid-19 or face health inequities resulting from social determinants of health, such as income and health care access?"

The CDC, the National Academies of Science, Engineering and Medicine and other advisers have proposed four groups that should get vaccinated first: health care personnel, other essential workers, adults with high risk medical conditions and other adults 65 and older.

That's a lot of people. The CDC estimates there are 21 million healthcare personnel, 87 million essential workers, 100 million adults with high risk medical conditions and 53 million others are 65 and older. The federal government has said 40 million coronavirus vaccine doses could be available by the end of December.

There's little disagreement that frontline healthcare workers should be in the first group -- designated as 1a. At issue is whether residents of long term care facilities should be in this group, also.

There's no question it's a highly vulnerable population. "Long term care facility residents and staff accounted for 6% of cases and 39% of deaths in the US, despite the fact that long term care facility residents account for less than 1% of the US population," the CDC's Dr. Kathleen Dooling told the meeting.

Plus, it's a group that would be easier to reach if the staff caring for them are already being immunized in the first phase of any vaccine that might get emergency authorization from the FDA.

But ACIP member Dr. Helen Keipp Talbot worried that this frail group might do poorly in general and damage faith in the vaccine.

"There is such a high mortality rate in long term care facilities," Talbot told the meeting. "There will be a number of patients who receive immunizations for Covid and will pass away. And it will be regardless of the vaccine and most likely will be regardless of the vaccine," Talbot said.

"But early on as we're building confidence and we will not be able to show any data to say that it was not due to the vaccine because there's not been a randomized, controlled trial. And I think we're going to have a very striking backlash of 'my grandmother got the vaccine and she passed away,' and they're not likely to be related, but that will become remembered and break some of the confidence in the vaccine."

But others did not think that putting these residents further back in line would help.

Hunter said it would be inefficient to vaccinate healthcare workers in the facilities but skip residents. "Why not vaccinate people that, you know, you, you've got it all set up and ready to go?" he asked. "It's an efficiency to vaccinate a bunch of people who could benefit from it."

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Covid-19 vaccine no 'walk in the park,' CDC committee told - CNN

Pfizer and Moderna have both announced promising results in the phase 3 trials of their COVID-19 vaccines. Here's how they differ. Storyful

The success of two COVID-19 candidate vaccines marks a turning point in the long history of vaccinesand could lead to major advances against a variety of diseases.

Vaccines developed by Pfizer/BioNTech and Moderna are more than 95% effective against COVID-19, trials show. Both depend on a technology never before used in a commercial vaccine that could upend the way future ones are made.

This new messenger RNA technology, as well another method that depends on viruses to deliver vaccines, are transforming the field, said Brendan Wren,a professor of vaccinology at the London School of Hygiene and Tropical Medicine.

"It could be quite a new era for vaccines and vaccinology," he said. "We seemed to move ahead in this one year 10 years."

These technologies had advanced enough that they were ready in time for this years burst of COVID-19-related funding and attention to be proved in human trials.

Its a silver lining of sorts to the pandemic. Without the urgency to find a solution to COVID-19, the money and the collaboration between government, academia and industry required for the breakthrough might not have come together for years, if ever.

"COVID is what made RNA jump to the head of the pack," said Dr. Drew Weissman, a professor of medicine at the University of Pennsylvania's Perelman School of Medicine.

Though messenger RNA technology hasn't grabbed headlines before now, a handful of researchers, including Weissman, have been working on it for decades.

"Actually, it feels like my entire life," said Weissman, who helped launch and lead the field since the 1980s.

Messenger RNAsare part of the body's toolkit used to turn a DNA blueprint into the proteins needed for every cellular activity. Weissman and other researchers tried for years toget the technology to work, butevery time they injected an experimental mRNA vaccine into an animal, it triggered dangerous inflammation.

However, advances in the science some credited to Weissman and his academic colleagues, others to government scientists or those in private industry have finally brought mRNA vaccines to the finish line.

The success serves as a reminder of the importance of basic science, said Dr. Barney Graham, a government researcher whose office has been collaborating with Moderna for nearly four years to advance their mRNA vaccine technology.

"Investment in basic science only helps," Graham said. "Even if it looks like some arcane idea that doesn't make sense, that kind of knowledge and basic understanding of biology and how things work are really informative to this kind of program."

AstraZeneca: COVID-19 vaccine candidate developed by Oxford 'highly effective' in trials

USA TODAY vaccine panel: 'Best news so far' in COVID-19 fight, but logistical challenges remain

The success of the companies' mRNA vaccines proves the technology is sound.Pfizer's completed trial of 44,000 people and Moderna's nearly finished trial of 30,000found the approach to be safe, causing no major health issues, and effective, protecting more than 95% of those vaccinated.

"All the boxes have now been checked. The platform clearly works," Anthony Fauci,head of the National Institute of Allergy and Infectious Diseases, said in a news conference announcing Moderna's effectiveness results.

He said he would have been satisfied had the mRNA vaccines been 70%-75% effective.

"Our aspirations have been met, and that's really very good news," Fauci said. "Help is on the way."

Messenger RNAs (in pink)turn a DNA blueprint into the proteins needed for every cellular activity.(Photo: Getty Images)

Advocates say messenger RNA vaccines have several advantages over traditional technologies.

They aren't grown in eggs or cells and don't have to go through the arduous purification of most vaccines, said Graham,deputy director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases.

"The more you can simplify things and just use exactly what you need and not anything more, overall it makes products safer and more likely to work," he said.

The mRNA vaccines can be developed quickly.

Moderna was ready to test its mRNA-1273 candidate vaccine in people about two months after receiving the genetic code of the virusfrom Chinese scientists. That's orders of magnitude faster than any vaccine ever before.

Infected again or endless COVID-19? How the 'reinfection phenomenon' could impact vaccines, herd immunity and human behavior

In clinical trials, the mRNA vaccines caused temporary side effects in 80%-90% of trial participants, but they were mild:Most had sore arms or felt cruddy for a day or two. No one fell seriously ill. Though that could change when vaccines are given to billions of people, the early results suggestbad reactions will be rare.

Messenger RNA vaccines contain only a fraction of the virus, so unlike some vaccines, they can't give people the disease they're trying to preventor trigger allergies to eggs or other traditional vaccine ingredients.

Most of the COVID-19 vaccines under development introduce copies of the same "spike" protein found on the surface of the virus that causes COVID-19. They train the immune system to recognize this protein and attack in case of infection.The mRNA vaccines direct the machinery of human cells to manufacture that spike protein.

The downside ismRNA molecules are fragile. To keep them from falling apart, researchers spent years figuring out how to encase the mRNAs in tiny droplets of fat.

In Pfizer/BioNTech's vaccine, that fat has to stay at super-cold temperatures, so it maintains its shape and shields the mRNA.

Moderna figured out how to maintain droplets for longer at warmer temperatures, so its vaccine needs to be stored at only normal freezing temperatures, or for up to a month in a fridge.

The fat droplet boosts the effectiveness of the vaccine, turning more cells into spike-protein-producing machines, Weissman said, which may be why they proved so effective against COVID-19.

"I am incredibly enthusiastic about these results," he said.

Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it. USA TODAY

It took years of work for Weissmanand a Penn colleague, Katalin Karik,tofind that if they swapped out one of the building blocks of RNA called a nucleoside not only would they solve their inflammation problem, the mRNA would make much more of the desired protein.

"We thought at that point it would be a great therapeutic," said Weissman, whose research is funded by BioNTech.

Weissman andKarik used their modified mRNA to make a hormone callederythropoietin, the absence of which causes a lack of red blood cells, leading to anemia.

"It worked beautifully," Weissman said. So far, the results are confined to a lab dish, mice and macaque monkeys. Someday, he hopes to test similar approaches against diseases in people.

In their lab, Weissman and his colleaguestested experimental vaccines against about 30 diseases. "It's looked great in just about all," he said.

COVID-19 vaccines are almost ready to be distributed:Who gets them after health care workers? Here's a list

Experimental mRNA vaccines have protected mice and ferrets against all types of flu. They appeared effective against genital herpes and malaria. They produced proteins that have gone missing in a wide variety of diseases, such as cystic fibrosis.

In addition to tackling COVID-19, Moderna has been developing mRNA vaccines against infectious diseases such asZika and chikungunya, as well as others to fight cancer.

Now that COVID-19 vaccines have proved the mRNA approach can work, there should be much more enthusiasm and money to pursue other mRNA vaccines and therapies.

"The potential is just enormous," Weissman said.

Katelyn Evans, 16, gets the first of two shots as part of a trial testing of Pfizer's COVID-19 vaccine in minors.(Photo: Cincinnati Children's Hospital)

Over the next few years, he and other scientists will work to reduce side effects from mRNA vaccines and therapies, while making them cheaper to manufacture, more stable at warmer temperatures and more potent so they can hopefully be given in one dose, instead of the two shots needed against COVID-19.

"My expectation is that those practical aspects, such as the temperature storage and stability over time at different temperatures, will continue to improve moving forward," said Dr. Dan Barouch,a professor of medicine at Harvard Medical Schooland director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, both in Boston.

Barouch and others dream of a vaccine that could be dispatched within a few months of a new outbreak.

"This (pandemic)would have evolved very differently if we had been able to immunize back in March," noted Dr. Bruce Walker,who directs the Ragon Institute of MGH, MIT and Harvard, which focuses on immunology and vaccine development.

"As we get more experience with these vaccines and as we learn from this pandemic how to actually scale up rapidly," he said, "I think more and more time can be shaved off."

A year ago, people would have said getting a vaccine developed and ready for the public within a year would be impossible. But two COVID-19 vaccines are likely to receive federal approval next month, and several more arent far behind.

"We've shown that's possible," Walker said. "And now we have to set our aspirations even higher."

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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Pfizer and Moderna use mRNA in their COVID-19 vaccines. This never-before-used technology could transform how science fights diseases. - USA TODAY

With 37%, the top reason some said 'no' in the Gallup poll was the fear that development of the vaccine was rushed.

NEW ORLEANS A third drug company has reached a milestone in its work to develop a COVID-19 vaccine.

Astra-Zeneca has cleared the first two phases and is now requesting emergency use of its vaccine, which it claims is up to 90-percent effective.

The company claims its vaccine is cheaper and easier to distribute than the ones developed by Pfizer and Moderna.

Now all of those companies are waiting on a panel of experts to finish reviewing the trials. That panel will weigh the benefits and risks of each vaccine and then present those findings to the Food and Drug Administration.

The public is also weighing the benefits and risks and an October poll from Gallup shows 58% of Americans are willing to get vaccinated as soon as they can.

"I will be first in line," said Beth Lasky when asked while walking in New Orleans City Park.

That leaves 42% surveyed who claim they wont.

"No ma'am," said Anthony Anthony Johnson, who was also asked in City Park. "I wasn't able to see personally what the vaccine will do or what was put in the vaccine so I can't just put it in my body."

"Just too many unknown factors," said Larryelle Mitchell.

With 37%, the top reason some said 'no' in the Gallup poll was the fear that development of the vaccine was rushed.

"I think speed was warranted," said Dr. Charles Stoecker, PhD, Assistant Professor with Tulane School of Public Health.

Most vaccines can take at least five years to get to the market. Using a new technology, these COVID vaccines were developed in less than a year. Stoecker said there's a good reason.

"This is a fast technology. It's easier to develop these mRNA vaccines," he said.

26% of those who said 'no' would not get the vaccine was they want to wait to confirm it's safe.

"That's a legitimate concern and that's why we have institutions in place to address that concern," Stoecker said referring to the trials happening now.

"For you and I, we don't have to be as brave as the people who volunteered in the clinical trials," he said.

According to the FDA, these major vaccine trials involve more than 30,000 people each.

"I think we still have some time. The trials will continue to run through the authorization process, they will have more time to document whether there are any adverse events of these vaccines," Stoecker said.

Of those who said 'no,' 12% said they don't trust vaccines in general.

"That's a problematic group," Stoecker said.

He believes the key is for enough people to get vaccinated to achieve herd immunity.

"We know from modelers that the number of people that need to be immune may be around 70 percent," Stoecker said.

One of his concerns is mistrust within the black community. That's a shadow of the horrific Tuskegee experiment. Presidents of Dillard and Xavier announced they participated in a clinical trial for a COVID vaccine. Stoecker thinks moves like that will increase willingness to get vaccinated.

"If Barack Obama gets it, I'll get it," Johnson said.

The first doses could be available this year, but time may be the biggest key to calm some of these fears.

Addressing another concern, the CDC said none of the vaccines in development use the live virus that causes COVID-19 so there is no chance you could become infected from the shots.

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Poll: 58% of Americans will take COVID-19 vaccine; here's why some say they wont - WWLTV.com

The mRNA vaccines do require cold storage, you are correct, but Pfizers vaccine, in particular, requires minus 70 degrees Celsius storage and so they have to come up with a way to basically store the vaccine and distribute the vaccine with that cold storage in mind. Modernas has less, their requirements are less strict, their vaccine can actually be stored in a standard freezer; it can actually be refrigerated for up to 30 days, said Morici.

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Louisiana knows what percentage of COVID-19 vaccines to expect; has vaccination playbook - FOX 8 Live WVUE

The safety of the COVID vaccine is on a lot of peoples minds these days. As multiple pharmaceutical companies release promising reports about the effectiveness of their COVID vaccines, it feels like a cure for this pandemic may be in sight. But for many people injecting a brand-new scientific discovery into their body doesnt sit well. So, how can we be sure that the cure wont be worse than the disease? How do regulators decide what an acceptable side effect is? And what would happen if someone did have a serious reaction to the COVID vaccine after it was released? This weeks episode of PODCAST-19 is devoted to answering those questions.

Dont want to miss an episode of PODCAST-19, FiveThirtyEights weekly look at what we know and what we know we dont know about COVID-19? Subscribe on your favorite podcasting app. For example, heres where to do it on Apple Podcasts and Spotify.

[Related: What To Make Of Pfizers Big Vaccine Announcement]

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How To Trust That A COVID-19 Vaccine Is Safe - FiveThirtyEight

Pfizer Inc. and partner BioNTech SE said they would ask the U.S. Food and Drug Administration on Friday to clear the companies Covid-19 vaccine. If the agency gives a thumbs-up, the shot would be the first to go into use in the U.S. Heres what we know and dont know.

Unclear, though the agency is expected to move quickly given the urgent need for a vaccine. It could take two or three weeks. The FDA must review data from the 44,000-subject trial on the vaccines safety and effectiveness....

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Pfizers Covid-19 Vaccine: FDA to Begin Review and Everything You Need to Know - The Wall Street Journal

The Associated Press checked out false and misleading claims and videos circulating after the presidential election and news about COVID-19 vaccines. This one is bogus, even though it was shared widely on social media.

CLAIM: Researchers used lung tissue from an aborted male fetus in the creation of COVID-19 AstraZeneca vaccine.

THE FACTS: As news continues to break around the results of new COVID-19 vaccines, a widely shared video made false claims about the vaccine developed through a partnership between the British pharmaceutical company AstraZeneca and Oxford University.

The video, which had more than 160,000 views, falsely claimed: CONFIRMED- aborted Male fetus in Covid 19 vaccine.

In the video, an unidentified woman shows the packaging from a box of AstraZeneca and Oxfords COVID-19 vaccine, and urges people to share the video with anybody else that doesnt want aborted fetal tissue fragments put into them. She then shows a preprint of a University of Bristol study that tested the vaccine on MRC-5 cell lines. She explains that the cell line was originally developed from an aborted male fetus.

Is everybody OK with having that injected into themselves or their children? the woman asks.

A spokesperson for AstraZeneca confirmed to the AP that the company does not use MRC-5 cells in the development of its vaccine.

Researchers at the University of Bristol, who were independent from the vaccines development, injected the COVID-19 vaccine into MRC-5 cell lines as part of their own study. MRC-5 cells are what is known as an immortalized cell line, which can reproduce indefinitely.

Such cell lines are used in vaccine production to grow viruses in order to keep them from replicating. The AstraZeneca and Oxford vaccine relies on a harmless chimpanzee cold virus to carry the coronavirus spike protein into the body in order to create an immune response.

AstraZeneca did not use MRC-5 cells, but it did use a different producer cell line to develop it: Human Embryonic Kidney 293 TREX cells.

According to the University of Oxford development team, the original Human Embryonic Kidney 293 cells were taken from the kidney of an aborted fetus in 1973, but the cells used now are clones of the original cells. Dr. Deepak Srivastava, president of Gladstone Institutes and former president of the International Society for Stem Cell Research, said fetal cell lines were critical in developing hepatitis, measles and chickenpox vaccines.

Whats important for the public to know even if they are opposed to the use of fetal cells for therapies, these medicines that are being made and vaccines do not contain any aspect of the cells in them, Srivastava said. The cells are used as factories for production.

Misinformation around COVID-19 vaccines have public health experts concerned about the implications it could have on the adoption of the vaccine in the United States.

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No cells from aborted fetus are in COVID-19 vaccines; that rumor is patently false - OregonLive